BEUDAMED
    FDA Recall Terminated

    CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

    Recall: Z-0264-2016 · Initiated October 22, 2015

    Recall

    Recall Number
    Z-0264-2016
    Event Number
    72475
    Firm
    Innokas Medical Oy Vihikari 10 Kempele Finland
    FEI Number
    3007615597
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    October 22, 2015
    Posted
    November 11, 2015
    Terminated
    July 1, 2016

    Description

    CARESCAPE VC150 Vital Signs Monitor Monitor vital signs in humans

    Reason

    Monitor may shut down unintentionally without restarting.

    Action

    The firm, Innokas Medical, sent a "Urgent Field Safety Notice(s)" dated October 22, 2015 and October 23, 2015 by e-mail to their consignees. The notice informed the distributor of the device, about the deficiency, and correction of the device. The notice included the instructions regarding what to do with the product and information that the devices will be updated. The consignees were instructed to complete and return the Medical Device FSCA/Recall Return Response Acknowledgement and Receipt Form via fax to +358 8 562 3151, mail to: Innokas Medical Oy, Vihikari 10, FI-90440-Kempele, Finland or email to: [email protected]. If you have any questions, contact the QA/RA Director at +358 44 562 3131.

    Distribution

    Worldwide Distribution: US (nationwide) and Europe.

    Quantity

    424 units (38 in US)